Written By: Pharmacally Medical News Desk
Johnson & Johnson announced on November 17, 2025, new long-term data from the Phase 3b APEX study demonstrating that their IL-23 inhibitor TREMFYA® (Guselkumab) is the only therapy in its class proven to substantially inhibit structural joint damage in adults with active psoriatic arthritis (PsA). Presented at the Inflammatory Skin Disease Summit 2025, the data showed that TREMFYA® not only significantly reduced radiographic progression at 24 weeks but also sustained this protective effect through 48 weeks. In addition to structural benefits, more than half of the patients treated with TREMFYA® across dosing regimens achieved a 50% improvement in PsA signs and symptoms. Johnson & Johnson highlighted that TREMFYA®, with its durable efficacy and established safety profile, sets a new benchmark as a first-line treatment option for patients living with psoriatic disease. The company also recently submitted supplemental data to the FDA to update TREMFYA®’s label reflecting its unique capability to inhibit joint damage progression in PsA.
The Phase 3b APEX study was a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of TREMFYA® (Guselkumab) in biologic-naïve adults with active psoriatic arthritis. The study enrolled patients who received either TREMFYA® every four weeks (Q4W), every eight weeks (Q8W), or placebo, with the primary endpoint assessing inhibition of structural joint damage progression at Week 24 using the PsA-modified van der Heijde-Sharp (vdH-S) scoring system. Secondary endpoints included measures of clinical response such as the American College of Rheumatology 50% improvement criteria (ACR50) and other signs and symptoms of PsA, evaluated through Week 48.
By Week 24, patients treated with TREMFYA® demonstrated a statistically significant and clinically meaningful reduction in structural joint damage progression compared to placebo, with a 2.5-fold greater inhibition of radiographic damage. This protective effect was sustained through Week 48, as patients continuing TREMFYA® treatment maintained minimal progression, confirming durable joint preservation. Patients who initially received placebo and switched to TREMFYA® at Week 24 saw a 57% reduction in radiographic progression through Week 48, indicating the treatment’s ability to reduce ongoing joint damage even in later-line settings. Additionally, over 50% of patients in both dosing regimens achieved ACR50 by Week 48, reflecting substantial improvement in PsA symptomatology.
The safety profile of TREMFYA® in the APEX study was consistent with previous trials, with no new safety signals identified. Adverse events were generally mild to moderate, and the incidence of serious adverse events was low, supporting TREMFYA® as a well-tolerated option for long-term management of active psoriatic arthritis. This comprehensive dataset reinforces the drug’s benefit-risk balance and its role as a valuable treatment for patients seeking disease-modifying therapy that addresses both symptoms and structural damage.
TREMFYA® selectively targets IL-23, a cytokine central to the activation and proliferation of Th17 cells that drive inflammation and joint damage in PsA. By inhibiting IL-23, Guselkumab reduces downstream inflammatory cytokines such as IL-17A and IL-22, effectively reducing inflammation and preventing structural joint damage. This mechanism distinguishes TREMFYA® as a targeted biologic option for patients, especially those who are biologic-naïve or have shown inadequate response to conventional therapies.
Dr. Ritchlin emphasized the chronic, progressive nature of psoriatic arthritis and the importance of TREMFYA®’s ability to inhibit joint damage even after it has begun, highlighting its value as a first-line treatment.
Leonard Dragone, MD, PhD, the Vice President at Johnson & Johnson Innovative Medicine, described the results as setting a new benchmark for IL-23 inhibitors in active PsA, pointing out the drug’s durable efficacy and robust safety that make TREMFYA® an attractive choice for patients with psoriatic disease.
This landmark evidence from the APEX study positions TREMFYA® as a leading therapeutic for inhibiting structural joint damage and improving quality of life in psoriatic arthritis, representing a significant advancement in IL-23 targeted treatment strategies.
References
New long-term data reinforces TREMFYA® (guselkumab) as the only IL-23 inhibitor proven to substantially inhibit structural joint damage in active psoriatic arthritis, Johnson and Johnson, 17 November 2025, https://www.jnj.com/media-center/press-releases/new-long-term-data-reinforces-tremfya-guselkumab-as-the-only-il-23-inhibitor-proven-to-substantially-inhibit-structural-joint-damage-in-active-psoriatic-arthritis
Philip J. Mease et al, Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: results through week 24 of the phase 3b, randomised, double-blind, placebo-controlled APEX study, Annals of the Rheumatic Diseases, 2025, https://doi.org/10.1016/j.ard.2025.08.006
A Study of Guselkumab in Participants with Active Psoriatic Arthritis (APEX), ClinicalTrials.gov ID NCT04882098, https://clinicaltrials.gov/study/NCT04882098